Sterility Retaining Medical Connector Assembly and Method

ABSTRACT

A medical connector assembly for establishing a fluid connection between a first medical device and a second medical device includes a multi-use connector and a plurality of single-use connectors connected in series. The multi-use connector has a proximal end opposite a distal end along a longitudinal length thereof. The plurality of single-use connectors each have a proximal end opposite a distal end along a longitudinal length thereof. The distal end of the multi-use connector is releasably connected to the proximal end of a first of the serially-connected single-use connectors. When a second of the serially-connected single-use connectors is disconnected from the first single-use connector, the first single-use connector remains connected to the multi-use medical connector as a sterility retaining cover.

CROSS REFERENCE TO RELATED APPLICATION

This application claims priority to U.S. Provisional Application No.61/548,862, filed Oct. 19, 2011 and entitled “Sterility RetainingMedical Connector Assembly and Method”.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This disclosure relates, in general, to the field of medical connectorsand, more particularly, to a medical connector assembly for retainingsterility of a reusable portion of the medical connector assembly.

2. Description of the Related Art

Typical medical connectors are provided for use with various medicaldevices, including dosage containers, administration sets, catheters,and medical lines. These connectors are commonly used in numerousmedical procedures where it is necessary to, for example, draw a drugfrom a container and/or deliver medical fluid(s) to one or morepatients. One example of such a connector is a rubber septum provided ona conventional drug vial and a needle for withdrawing a quantity of thedrug from the drug vial. Each time the drug vial is accessed for thepurpose of withdrawing a quantity of the drug therefrom, the rubberseptum is typically disinfected with a disinfectant, such as alcohol.The user then pierces the rubber septum with a needle to withdraw aquantity of the drug from the drug vial. After withdrawing the needlefrom the rubber septum, the elastic nature of the septum materialre-seals the drug vial thereby maintaining a sealed connection betweenthe interior and exterior of the drug vial. The user may then utilizethe needle to deliver the drug to the patient. In this example, theneedle may be considered to be a single use connector that is used onlyonce for each patient and then disposed of as medical waste.

Another example of a medical connector is a swabbable valve and acorresponding single use connector. In this example, the user must swabthe connection valve with a disinfectant, such as alcohol, to clean theconnection surface before mating the connection valve to the single useconnector. The single use connector may be a luer fitting. Commonly,swabbable valves must be swabbed for at least 15 seconds with adisinfectant, after which a waiting period of at least 45 seconds isrequired for the disinfectant to evaporate. In practice, it is often thecase that the connection valve is not disinfected for a proper length oftime, if at all.

Conventional medical connectors are generally provided inpre-sterilized, sealed packages prior to use. A user, such as a medicalpractitioner, must remove the medical connector prior to use. While itis possible to maintain sterility in manufacturing and packaging ofmedical connectors, various sources of contamination may be introducedas soon as the medical connector is removed from the pre-sterilized,sealed package. For example, airborne particles, such as germs indroplets from coughs or sneezes, may accumulate on a fluid connectionelement of the medical connector, thereby contaminating it. Spores anddust are additional airborne particulates that may contaminate themedical connector. In use, the medical connector may be contaminated byinadvertent contact with a non-sterile material, such as the clothing orbody of a medical practitioner or a patient. Sterility may be furthercompromised in the process of making a connection between a medicalconnector and a medical container by touching a non-sterile surface.

Even though various medical connectors of myriad designs have been usedfor many years, they are associated with a number of drawbacks. Duringuse, it is essential that all contact with non-sterile surfaces isavoided and that exposure to airborne contaminants is reduced,minimized, or eliminated. Each time a fluid connection is establishedbetween a medical article, such as a syringe, a dosage container, or apump, and a fluid line connected to a patient, such as connected to acatheter inserted into the patient, a new, sterile medical connectorshould be used to connect the fluid line between the medical article andthe patient. However, sterility of connection between various medicalconnector components is often compromised once the medical connector istaken from a sterile environment, such as its packaging. Conventionalmedical connectors are often provided with dust caps to preventinadvertent contact with non-sterile surfaces or airborne contaminants.For example, U.S. Pat. No. 2,780,243 (Williams et al.) and U.S. Pat. No.3,987,930 (Fuson) disclose respective embodiments of stackable ornestable dust caps that are suitable for extended storage, and U.S. Pat.No. 4,778,447 (Velde et al.) discloses a medical connector with bothmale and female protective caps. However, these means of maintainingsterility are not always utilized in practice. Additionally, providingdust caps on each connector component increases the complexity of sucharticles, making them prohibitively costly in many instances due totheir single use nature as well as increasing the amount of wasterequiring disposal.

Various two-piece medical connectors are also known in the medicalfield, such as from U.S. Pat. No. 4,981,469 to Whitehouse et al. andU.S. Pat. No. 7,241,285 to Dikeman. Whitehouse et al. is directed to anassembly for connection to a medicant supply tube and includes a septumassembly including a distal end cap, a septum cap, and an externaladapter. Dikeman discloses a medical connector for connecting a fluidpassage device, such as may be provided by a luer taper, and aninjection site having a thin diaphragm. The medical connector includes areduced diameter cannula for engaging the thin diaphragm sufficiently toopen the thin diaphragm to establish an open fluid passage. U.S. Pat.No. 6,911,025 to Miyahara is directed to a dialysis connector in which apatient side connector is enclosed by a long term use protective capwhich encloses a sterile inner cap that is replaced at the conclusion ofeach dialysis procedure.

Each of the foregoing designs is based on single use connector that theuser must replace before making a new fluid connection between a medicalarticle and a patient. Because of their single use design, conventionalmedical connectors require the user to ensure that proper sterilizationprecautions are taken each time a new connection is required.Additionally, there exists a significant risk of contamination due tohuman error in placing and removing dust caps from single useconnectors. Furthermore, because no parts of conventional medicalconnector designs are reusable, large stockpiles of medical connectorsmust be kept on premises, which increase storage costs and per procedurecosts.

The discussion has centered upon the fluid supply side of the fluiddelivery system. There are similar or even greater issues, needs, andproblems on the patient receiving side where because of the physicalpain or discomfort to the patient and the healthcare worker's difficultyof getting vascular access to the patient, there is often the need forsequential delivery or withdrawal of fluids from a single patientvascular access device over the time of their treatment. This iscurrently solved by using swabbable valves mentioned above or needlelesssepta. Both of these have significant problems as described above. Inaddition, it is desirable to have features that reduce the opportunityfor blood from a patient to get into the environment.

SUMMARY OF THE INVENTION

In view of the foregoing, a need exists for a medical connector assemblyfor retaining sterility of a reusable or multi-use connector or element.For example, the medical connector assembly may be used to establish afluid connection between a first medical device and a second medicaldevice. In one embodiment, the medical connector assembly comprises amulti-use connector and a plurality of single-use connectors connectedin series. The multi-use connector has a proximal end opposite a distalend along a longitudinal length thereof. The plurality of single-useconnectors each has a proximal end opposite a distal end along alongitudinal length thereof. The distal end of the multi-use connectoris releasably connected to the proximal end of a first of theserially-connected single-use connectors. When a second of theserially-connected single-use connectors is disconnected from the firstsingle-use connector, the first single-use connector remains connectedto the multi-use medical connector as a sterile cover. Removable capsmay be provided to cover the distal end of the multi-use connector andthe proximal end of the first single-use connector for sterility, suchas prior to use.

A sheath may be disposed about the medical connector assembly and maycomprise a first sheath element having a frangible connection to asecond sheath element. The sheath may extend over the exterior of themedical connector assembly to extend from the multi-use connector andcontinue along the serially-connected single use connectors. When thesecond of the serially-connected single-use connectors is disconnectedfrom the first single-use connector, the sheath is disrupted such thatthe second single-use connector cannot be easily reattached, or isentirely prevented from being reattached, to the first single-useconnector. After the disruption, the first sheath element may remaindisposed about the first single-use connector and a portion of themulti-use medical connector and the second sheath element may remaindisposed about the disconnected second single-use connector such thatthe second single-use connector cannot be easily reattached, or isentirely prevented from being reattached, to the first single-useconnector.

A fluid path element may be connected to the distal end of the secondsingle-use connector. The fluid path element may comprise a low pressureconnector tube adapted for connection to a catheter. The multi-useconnector may be provided on a syringe neck connection of a syringe.

Another embodiment described in detail herein is directed to a method ofestablishing and retaining a sterile fluid connection in a medicalconnector assembly. The method may comprise providing a multi-useconnector comprising a proximal end opposite a distal end along alongitudinal length thereof, and providing a plurality of single-useconnectors connected in series and each comprising a proximal endopposite a distal end along a longitudinal length thereof. The methodmay further comprise connecting the distal end of the multi-useconnector to the proximal end of a first of the serially-connectedsingle-use connectors. Further, the method may further comprisedisconnecting a second of the serially-connected single-use connectorsfrom the first single-use connector, such that the first single-useconnector remains connected to the multi-use medical connector as asterile cover.

A removable cap may be provided on the distal end of the multi-useconnector for sterility, and the method may further comprise removingthe cap prior to the step of connecting the distal end of the multi-useconnector to the proximal end of the first single-use connector.Additionally, a removable cap may be provided on the proximal end of thefirst single-use connector for sterility, and the method may furthercomprise removing the cap prior to the step of connecting the distal endof the multi-use connector to the proximal end of the first single-useconnector.

A sheath may be disposed about the medical connector assembly andcomprise a first sheath element having a frangible connection to asecond sheath element. When the second single-use connector isdisconnected from the first single-use connector, the frangibleconnection is broken. The sheath may extend over the exterior of themedical connector assembly to extend from the multi-use connector andcontinue along the serially-connected single-use connectors. Further,when the second of the serially-connected single-use connectors isdisconnected from the first single-use connector, the sheath isdisrupted such that the second single-use connector cannot be easilyreattached, or is entirely prevented from being reattached, to the firstsingle-use connector. After the disruption, the first sheath element mayremain disposed about the first single-use connector and a portion ofthe multi-use medical connector and the second sheath element may remaindisposed about the disconnected second single-use connector to bedisposed of with the second-single use connector.

The method may include providing a fluid path element connected to thedistal end of the second single-use connector. The fluid path elementmay comprise a low pressure connector tube adapted for connection to acatheter. The multi-use connector may be provided on a syringe neck of asyringe. Alternatively, the multi-use connector may be on any type offluid path element, such as a container, a tube from a supply of medicalfluid and the opposing single-use connector may be on the neck of asyringe.

The step of disconnecting the second single-use connector from the firstsingle-use connector may comprise twisting the second single-useconnector relative to the first single-use connector and axiallydetaching the second single-use connector from the first single-useconnector.

The multi-use connector and each one of the plurality ofserially-connected single-use connectors may comprise an internal flowcontrol element.

The step of connecting the distal end of the multi-use connector to theproximal end of the first of the serially-connected single-useconnectors may be accomplished in a sterile airflow. The sterile airflowmay be generally parallel or generally perpendicular to an intendedfluid flow direction through the medical connector assembly. Forexample, the sterile airflow may be generally parallel or generallyperpendicular to a direction of approach between the multi-use connectorand the opposing single-use connector.

In another embodiment, a medical connector assembly is providedcomprising a multi-use connector and a plurality of single-useconnectors connected in series. The multi-use connector is releasablyconnected to a first of the serially-connected single-use connectors andwhen a second of the serially-connected single-use connectors isdisconnected from the first single-use connector, the first single-useconnector remains connected to the multi-use medical connector as asterility retaining cover.

The multi-use connector may be provided on a discharge neck of asyringe.

The first single-use connector may be in threaded engagement with themulti-use connector.

The first single-use connector may be comprised of two connectorelements fitted together in interfering engagement.

A frangible sheath may be disposed about the medical connector assemblyand comprise a first sheath element having a frangible connection alonga circumferential notch to a second sheath element.

The second single-use connector may be adapted to break apart along acircumferential notch such that, upon breaking, a portion of the secondsingle-use connector is retained with the opposing first single-useconnector.

The second single-use connector may be comprised of a first connectorelement and a second connector element, with the first connector elementdefining a head portion comprising a depending portion adapted forsliding engagement into a mating receptacle defined in the secondconnector element. A frangible sheath may secure the first connectorelement in engagement with the second connector element.

The second single-use connector may be comprised of a first connectorelement and a second connector element, with the first connector elementdefining a head portion and the second connector element comprisingopposed folding elements that fold over the head portion. A frangiblesheath may secure the first connector element in engagement with thesecond connector element.

The second single-use connector may be comprised of a first connectorelement and a second connector element in abutting engagement heldtogether by a frangible shrink wrap sheath, such as shrink wrap, anover-molded clamp, a clamp with a living hinge and catch, a spring clip,or another similar element, apparatus, or methodology in whichintentional exertion force is used to overcome a retention force.

The first single-use connector may be in threaded engagement with themulti-use connector, and a threaded sheath may be in threaded engagementwith the first single-use connector. The threaded engagement between thesheath and the first single-use connector may be oppositely operatedfrom the threaded engagement between the first single-use connector andthe multi-use connector. The second single-use connector may be inthreaded engagement with the sheath to secure the second single-useconnector in series with the first single-use connector.

The single-use connectors may be integrally formed and adapted to breakinto at least two elements along a circumferential notch.

A sheath may be disposed about the medical connector assembly andcomprise a first sheath element having a frangible connection to asecond sheath element. The sheath may extend over the exterior of themedical connector assembly to extend from the multi-use connector andcontinue along the serially-connected single use connectors. Further,when the second single-use connector is disconnected from the firstsingle-use connector, the first sheath element may remain disposed aboutthe first single-use connector and a portion of the multi-use medicalconnector, and the second sheath element remains disposed about thedisconnected second single-use connector.

Further details and advantages will be understood from the followingdetailed description read in conjunction with the accompanying drawingsfigures.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a block diagram view of an embodiment of a multi-use connectorassembly.

FIG. 2 is a block diagram view of an embodiment of a single-useconnector assembly.

FIG. 3 is a block diagram view of the single-use connector assembly ofFIG. 2 shown connected with the multi-use connector assembly of FIG. 1to form a medical connector assembly.

FIG. 4 is a block diagram view of a portion of the medical connectorassembly shown in FIG. 3.

FIG. 5 is a block diagram view of the medical connector assembly of FIG.3 shown in conjunction with a stream of sterile air that flows generallyparallel to the direction of fluid flow through the medical connectorassembly.

FIG. 6 is a block diagram view of the medical connector assembly of FIG.3 shown in conjunction with a stream of sterile air that flows generallyperpendicular to the direction of fluid flow through the medicalconnector assembly.

FIG. 7 is a schematic view of the medical connector assembly prior toconnection of the single-use connector assembly of FIG. 2 with themulti-use connector assembly of FIG. 1.

FIG. 8 is a schematic view of the medical connector assembly of FIG. 7after connection of the single-use connector assembly of FIG. 2 with themulti-use connector assembly of FIG. 1.

FIG. 9 is a schematic view of the medical connector assembly of FIG. 7after the single-use connector assembly has been partially disassembledso that a portion of the single-use connector assembly and the multi-useconnector assembly may be discarded.

FIG. 10 is a schematic view of the medical connector assembly prior toconnection of the single-use connector assembly of FIG. 2 with themulti-use connector assembly of FIG. 1, and further shown in anenvironment for filling a syringe with fluid.

FIG. 11 is a schematic view of the medical connector assembly of FIG. 10after connection of the single-use connector assembly of FIG. 2 with themulti-use connector assembly of FIG. 10.

FIG. 12 is a schematic view of the medical connector assembly of FIG. 10after the single-use connector assembly has been partially disassembledso that a portion of the single-use connector assembly and the multi-useconnector assembly may be discarded.

FIG. 13 is a block diagram view of another embodiment of the multi-useconnector assembly of FIG. 1.

FIG. 14 is a block diagram view of another embodiment of the single-useconnector assembly shown in FIG. 2.

FIG. 15 is a block diagram view of the single-use connector assembly ofFIG. 14 shown connected with the multi-use connector assembly of FIG. 13to form another embodiment of the medical connector assembly.

FIG. 16 is a schematic view of another embodiment of the medicalconnector assembly.

FIG. 17 is an exploded perspective view of another embodiment of themedical connector assembly suited for high pressure applications such aswith an angiographic syringe.

FIG. 18 is a perspective end view of the single-use connector assemblyused in the medical connector assembly of FIG. 17.

FIG. 19 a perspective view of the medical connector assembly and syringeshown in FIG. 17.

FIG. 20 is a cross-sectional view taken along line 20-20 in FIG. 19.

FIG. 21 is an exploded perspective view showing the single-use connectorassembly of the medical connector assembly of FIG. 17.

FIG. 22 is an exploded perspective view of another embodiment of themedical connector assembly in which a frangible connection may beprovided as part of the single-use connector assembly.

FIG. 23 is a perspective end view of the single-use connector assemblyused in the medical connector assembly of FIG. 22.

FIG. 24 a perspective view of the medical connector assembly and syringeshown in FIG. 22.

FIG. 25 is a cross-sectional view taken along line 25-25 in FIG. 24.

FIG. 26 is an exploded perspective view showing the single-use connectorassembly of the medical connector assembly of FIG. 22 in a disconnectedstate.

FIG. 27 is an exploded perspective view of another embodiment of themedical connector assembly in which a slidable connection may beprovided as part of the single-use connector assembly.

FIG. 28 is an exploded perspective view of the single-use connectorassembly used in the medical connector assembly of FIG. 27 shown in adisconnected state.

FIG. 29 is another exploded perspective view of the single-use connectorassembly used in the medical connector assembly of FIG. 27 shown in adisconnected state.

FIG. 30 is a longitudinal cross-sectional view of the medical connectorassembly of FIG. 27.

FIG. 31 is a perspective view of a modification of the single-useconnector assembly shown in FIGS. 27-30.

FIG. 32 is a perspective view of the single-use connector assembly shownin FIG. 31 with a shrink-wrap sheath element removed.

FIG. 33 is an exploded perspective view of the single-use connectorassembly FIG. 31.

FIG. 34 is an exploded perspective view of another embodiment of themedical connector assembly in which a fluid connection may be maintainedby a shrink wrap sheath element.

FIG. 35 is a longitudinal cross-sectional view of the medical connectorassembly of FIG. 34.

FIG. 36 is a perspective view of another embodiment of the medicalconnector assembly associated with an angiographic syringe.

FIG. 37 is a cross-sectional view taken along line 37-37 in FIG. 36.

FIG. 38 is an exploded perspective view of another embodiment of themedical connector assembly associated with an angiographic syringe.

FIG. 39 is an end view showing an engaged state of the medical connectorassembly and syringe of FIG. 36.

FIG. 40 is a perspective view showing an engaged and locked state of themedical connector assembly and syringe of FIG. 36.

FIG. 41 is an end view showing the engaged and locked state of themedical connector assembly and syringe as shown in FIG. 40.

FIG. 42 is a cross-sectional view showing the engagement of the medicalconnector assembly and syringe of FIG. 36.

FIG. 43 is a schematic perspective view of another embodiment of themedical connector assembly exhibiting a sliding connection between thesingle-use connector assembly and the multi-use connector assembly.

DETAILED DESCRIPTION OF THE INVENTION

For purposes of the description hereinafter, spatial orientation terms,if used, shall relate to the referenced embodiment as it is oriented inthe accompanying drawing figures. or otherwise described in thefollowing detailed description. However, it is to be understood that theembodiments described hereinafter may assume many alternative variationsand embodiments. It is also to be understood that the specific devicesillustrated in the accompanying drawing figures and described herein aresimply exemplary and should not be considered as limiting. The terms“longitudinal” and “serial” as used in connection with relationship ofparts, features, or elements in this disclosure, while generallyillustrated as straight lines in the figures, are not intended to beexclusively limited to linear or straight line relationships.

Referring to the figures in which like reference characters refer tolike parts throughout the several views thereof, a medical connectorassembly 10 (hereinafter “connector assembly 10”) and method forretaining sterility of a reusable portion of the connector assembly 10will be described herein in detail. With initial reference to FIGS. 1-3,the assembled connector assembly 10, as shown in FIG. 3, generallycomprises a multi-use connector assembly 100 removably coupled to asingle-use connector assembly 200. As described in detail herein, thesingle-use connector assembly 200 includes a plurality of single-useconnector elements 201, 202, for example sequentially connected togetherin series to form a chain, a fluid path, or a fluid channel. Eachsingle-use connector element 201, 202 (hereinafter “single-useconnectors 201, 202”) is generally a hollow, tubular structure made froma material suitable for medical applications, such as medical gradeplastic. Similarly, the multi-use connector assembly 100 comprises amulti-use connector element 101 (hereinafter “multi-use connector 101”)that is generally a hollow, tubular structure made from a materialsuitable for medical applications, such as medical grade plastic. It maybe desirable to construct the multi-use connector 101 and/or thesingle-use connectors 201, 202 from a clear medical grade plastic inorder to facilitate visual verification that a fluid connection has beenestablished between these elements of the connector assembly 10 andvisually detect the presence of air in the connector assembly 10.Additionally, one or more fluid path elements 300, such as medicaltubing 302 in an exemplary embodiment, may be provided with (e.g., partof) or be connected to the single-use connector assembly 200 to enablefluid communication between the multi-use connector 101 and thedownstream fluid path element 300 via the single-use connector assembly200. The fluid path element 300 may alternatively be a catheter or othersimilar fluid path element.

With specific reference to FIG. 1, the multi-use connector assembly 100is shown in a state after removal from its packaging (not shown). Themulti-use connector assembly 100 is desirably packaged in apre-sterilized, sealed package that protects the multi-use connectorassembly 100 from contamination with air or surface-borne contaminants.The multi-use connector assembly 100 generally comprises a multi-useconnector 101 and a removable dust cap 110 which protects the multi-useconnector assembly 100 from inadvertent contamination as it is removedfrom the packaging and before it is connected to the single-useconnector assembly 200, as described herein. The cap 110 may beair-tight or vented. Additionally, the cap 110 may have a plurality oflongitudinal ribs (not shown) on the external sidewall thereof toprovide a convenient gripping surface for the user to remove the cap 110from the multi-use connector 101.

The multi-use connector assembly 100 may be, for example, removablyattached to or, alternatively, part of a syringe, fluid pump device, andlike fluid delivery devices which are used to deliver fluid underpressure to the downstream fluid path element 300 via the single-useconnector assembly 200. Additionally, the multi-use connector assembly100 may be, for example, removably attached to or, alternatively, partof a medical tubing set, a catheter, or other fluid path or conductingelement, which is used to receive multiple sequential doses of fluidincluding, for example, a catheter or port in a patient. The multi-useconnector 101 has a proximal side or end 101 a opposite a distal side orend 101 b along the longitudinal length of the multi-use connector 101.The proximal side 101 a of the multi-use connector 101 is oftenconnected to a fluid source (not shown in FIG. 1), such as a contrastsolution container or a drug container or, as indicated in theforegoing, may be removably connected to or be part of a fluid deliverydevice such as a syringe or fluid pump device that is used to deliverfluid under pressure. The distal end 101 b of the multi-use connector101 is enclosed by the removable cap 110 which protects the distal end101 b of the multi-use connector 101 from inadvertent contaminationafter it is removed from the packaging. The distal end 101 b of themulti-use connector 101 is generally adapted for fixed and fluid-tightconnection with one of the single-use connectors 201, 202, namely theproximal-most or upstream single-use connector 201 in the chain ofconnectors 201, 202 in the single-use connector assembly 200. A dottedarrow 99(1) in FIG. 1 shows the direction of fluid flow through themulti-use connector 101 during use in a fluid delivery procedure. Themulti-use connector 101 may optionally include an internal flow controlelement 111, such as a slit diaphragm or a one-way or two-way checkvalve, which prevents fluid flow until a sufficient pressure differenceacross the internal flow control element 111 is reached. In this manner,the flow control element 111 prevents fluid from an associated fluidsource container, fluid delivery device (e.g., pump or syringe), orfluid path set, from dripping from the multi-use connector 101.

Alternatively, if flow under low pressure conditions, such as gravitydriven flow, is desired, as well as resistance to flow whendisconnected, the internal flow control element 111 may be a refluxvalve that functions similar to those used in needleless connectors,such that the insertion of the single-use connector assembly 200 opensthe internal flow control element 111 so that fluid can flow withminimal pressure differential. Common methods to accomplish this resultare shown in Needleless Connectors: A Primer on Terminology, by LynnHadaway, MEd, RNC, CRNI® and Deb Richardson, MS, RN, CNS, Journal ofInfusion Nursing; VOL 33|NUM 1|January/February 2010 which isincorporated herein by reference.

With reference to FIG. 2, the single-use connector assembly 200 is shownin an initial state after removal from its packaging (not shown). Aswith the multi-use connector assembly 100 shown in FIG. 1, thesingle-use connector assembly 200 is desirably packaged in apre-sterilized, sealed package that protects the single-use connectorassembly 200 from contamination with air or surface-borne contaminants.A removable dust cap 210, similar to the cap 110, protects thesingle-use connector assembly 200 from contamination after it is removedfrom the packaging and before it is connected to the multi-use connectorassembly 100. The cap 210 may be air tight or vented and may includesimilar gripping features to the cap 110 discussed previously. The caps110, 210 are desirably provided as sterility retaining caps or covers,but may be any device or feature that helps preserve sterility byreducing the likelihood or preventing accidental contact with surfacesand/or contact by airborne contaminants; suitable embodiments include adust cap, lid, cover, seal, membrane, sterility retaining cover, orsterility maintaining cover.

The single-use connector assembly 200 generally includes a plurality ofsingle-use connectors 201, 202 sequentially connected together in seriesto form a chain, a fluid path, or a fluid channel, as mentionedpreviously. Each single-use connector 201, 202 is generally a hollow,tubular structure made from a material suitable for medicalapplications, such as medical grade plastic, as noted previously. Adotted arrow 99(2) in FIG. 2 shows the direction of fluid flow throughthe single-use connector assembly 200 during use in a fluid deliveryprocedure.

The first or proximal single-use connector 201 has a proximal side orend 201 a and a distal side or end 201 b. Similarly, the second ordistal single-use connector 202 has a proximal side or end 202 a and adistal side or end 202 b. The proximal end 201 a of the first single-useconnector 201 in the chain of single-use connectors 201, 202 isprotected by the removable cap 210 prior to connection with themulti-use connector 101. The distal end 201 b of the first single-useconnector 201 is connected to the proximal end 202 a of the successivesingle-use connector 202. In turn, the distal end 202 b of thesuccessive single-use connector 202 may be connected to a fluid pathelement 300 which may be, for example, medical tubing 302, or optionallya catheter fluid path set or other fluid conducting element, a syringe,a fluid pump device, a fluid container, etc. Each single-use connector201, 202 desirably includes an internal flow control element 211, 212,such as a flexible or resilient slit diaphragm, one-way check valve,reflex valve or other equivalent structure, which prevents fluid flowunder low pressures in either direction when the distal end 201 b of thefirst single-use connector 201 is separated from the proximal end 202 aof the successive single-use connector 202. The downstream fluid pathelement 300 may also include a similar flow control element 311 havingsimilar or identical structure and function to the flow control elements211, 212 in each of the single-use connectors 201, 202. The flow controlelement 311 of the fluid path element 300 prevents fluid movement undergravity or low-pressure conditions so that when the second single-useconnector 202 is ultimately disconnected from the multi-use connector101, as described herein, minimal or no fluid drips from the fluid pathelement 300.

Alternatively, if flow under low pressure conditions, such as gravitydriven flow, is desired, as well as resistance to flow whendisconnected, the internal flow control elements 211, 212, and/or 311may be reflux valves that function similar to those used in needlelessconnectors, such that the insertion of the upstream or downstreamelement(s) opens the internal flow control element(s) so that fluid canflow with minimal pressure differential. The internal flow controlelement(s) can be designed and come assembled such that they are held inthe open position by an upstream or downstream fluid path element andmove to the closed position upon separation of that restraining fluidpath element.

The fluid path element 300 may be replaced by a suitable removable capsimilar to the removable cap 210 connected to the distal end 202 b ofthe second single-use connector 202 if so desired, for example to enablealternative or non-preassembled fluid path elements to be utilized. FIG.2 further illustrates a sheath 251 comprising a first or proximal sheathelement 251 a and a second or distal sheath element 251 b as an optionalelement of the single-use connector assembly 200. The sheath 251 istypically frangible and extends over the exterior of the connectorassembly 10, preferably extending from the multi-use connector 101 andcontinuing along the single-use connector assembly 200. The sheath 251helps prevent accidental or intentional misuse as will be explainedhereinafter. The connection of the multi-use connector assembly 100 withthe single-use connector assembly 200 optionally having a connectedfluid path element 300 forms the overall connector assembly orarrangement 10.

Specific mechanical details of the connection between the multi-useconnector 101 and the first single-use connector 201 are notspecifically illustrated in FIGS. 1-6 because the connection may beestablished in a number of ways. For example, the multi-use connector101 may have a threaded male luer connection and the first single-useconnector 201 may have a mating threaded female luer connection, or viceversa. The male or female luer connections may be provided at either thedistal or proximal ends of the multi-use connector 101 and within thesingle-use connectors 201, 202. This specific and non-limiting matingluer connection arrangement is shown in FIGS. 7-12, which will bediscussed in greater detail hereinafter.

Another alternative for making a fluid-tight connection between themulti-use connector 101 and the first single-use connector 201, as wellas within the connections between the single-use connectors 201, 202, isa bayonet connection where a male end on one of the multi-use connector101 and the first single-use connector 201 has one or more pins whichengage a matching slot provided on the female end of the other of themulti-use connector 101 or the first single-use connector 201. A similarconnecting arrangement may be provided between the first and secondsingle-use connectors 201, 202. Alternatively, the connector assembly 10may include an axial “push and catch” type of connection where the maleend on one of the multi-use connector 101 and the first single-useconnector 201 is inserted into the female end of the other of themulti-use connector 101 and the first single-use connector 201. Again, asimilar connecting arrangement may be provided between the first andsecond single-use connectors 201, 202. Other possible embodiments ofmechanical connection between the various connecting components of theconnector assembly 10 include face-sliding attachment, barbed fittings,collet fittings, compression fittings, clamp fittings, and bonding orbreakable attachments. One of ordinary skill in the art will recognizethat this listing of connection alternatives for making fluid-tightconnections between the mating components of the connector assembly 10is not exhaustive and other equivalent mechanical connectingarrangements may be provided. Additionally, various combinations andpermutations of the foregoing-described mechanical connectingarrangements may be employed in accordance with this disclosure.Accordingly, in the depicted embodiment in the accompanying figures, thefirst single-use connector 201 in the single-use connector assembly 200is inserted into/onto the multi-use connector 101 of the multi-useconnector assembly 100 until a fluid tight connection is established.Next, the fluid path element 300 may be connected to the distal end 202b of the second single-use connector 202, or the fluid path element 300may be provided as part of, such as integral with, the second single-useconnector 202.

The connection between the mating elements of the connector assembly 10may also include a seal (not shown) at the interface between the matingelements. For example, a seal may be provided at the proximal end, thedistal end, or both on the multi-use connector 101 and/or the single-useconnectors 201, 202. The seal forms a fluid-tight connection between themating elements and prevents fluid from a fluid source container, afluid delivery device, medical tubing, etc., from dripping through theinterface between the mating elements of the connector assembly 10. Inone exemplary embodiment, the seal may be a taper seal which is formedbetween a tapering surface on a first mating element and a taperingsurface on the opposing second mating element of the connector assembly10 as is done with a conventional luer connector. Alternately, the sealmay be in the form of a face seal or an O-ring provided on the matingsurface of a mating element. Further, the seal may be formed by heatingthe mating elements or otherwise bonding them to create a fluid-tightconnection. Further, the seal may be accomplished by multi-shot molding,over molding, or by incorporating the function of the two connectorsinto one physical piece which “breaks” upon separation.

In the single-use connector assembly 200, the sheath 251 is generallyprovided to increase the reliability and/or improve human factorreliability of the attachment and detachment process between themulti-use connector 101 and the single-use connectors 201, 202. In oneembodiment, as shown in FIGS. 1-3, the sheath 251 is separated into afirst sheath element 251 a and a second sheath element 251 b byserrations for frangibility, as mentioned previously. The sheath 251 mayalso contain gripping members 251 z on the proximal end of the firstsheath element 251 a that are adapted to grip the exterior of themulti-use connector 101. As noted previously, the multi-use connector101 may be a fluid delivery device such as a syringe or a fluid pumpdevice, or could also be another fluid conducting component such as avalve port on a stopcock valve, etc. In use, as the first single-useconnector 201 is attached to the multi-use connector 101, the grippingmembers 251 z on the first sheath element 251 a are attached to themulti-use connector 101 in a non-rotationally removable manner. As anexample, the gripping members 251 z could be ratchets or ramped elementsthat slide over oppositely faced ramps on the exterior surface of themulti-use connector 101 to allow the single-use connectors 201, 202 tobe rotated for attachment, but do not allow rotation for the detachmentof the first single-use connector 201 from the multi-use connector 101.Alternatively, the gripping members 251 z can be metal teeth or barbswhich are slanted such that they rotate freely in one direction and diginto the wall of the multi-use connector 101 and prevent rotation in theother direction, or which are positioned and angled to allow motionproximally onto the multi-use connector 101 but prevent motion in thedistal direction. In this manner, when it is desired to remove thesecond single-use connector 202 from connection with the firstsingle-use connector 201, the user grips the second sheath element 251 band twists. This twisting motion tears serrations or a thinned elementor section (not shown) thereby separating the second sheath element 251b from the first sheath element 251 a and, further, separates the firstsingle-use connector 201 from the adjoining single-use connector 202,with the first single-use connector 201 remaining in fluid connectionwith the multi-use connector 101. The single-use connector 201 thatremains connected to multi-use connector 101 now serves the function ofa removable “cap” for the multi-use connector 101. The removedsingle-use connector 202 and any connected fluid path element 300 may besafely disposed of as medical waste. When it is desired to connect a“new” single-use connector assembly 200 to the multi-use connector 101,it is only necessary to remove the remaining single-use connector 201from the multi-use connector 101. In this example, the first sheathelement 251 a may be short enough so that the operator can grip just theremaining single-use connector 201 and twist to disconnect it from themulti-use connector 101. The first sheath element 251 a can then bepulled off axially from the multi-use connector 101 as the retained“cap” single-use connector 201 is removed. Optionally, the sheath 251generally, or the sheath element 251 b in particular, may be configuredto cooperate with structures on the multi-use connector 101 or thesingle-use connectors 201, 202 so that it is difficult or impossible tosimply and reliably reconnect the second single-use connector 202 to thefirst single-use connector 201 for use with subsequent patients.

Alternatively, rather than having the sheath 251 separate into two partsduring the removal of the single-use connector 202, the sheath 251 maysplit, stretch, or otherwise act so that the single-use connector 202can be removed. Such action by the sheath 251 helps ensure that thesingle-use connector 202 is preferentially removed from the single-useconnector 201 rather than the single-use connector 201 being removedfrom the multi-use connector 101. The action of the sheath 251 alsohelps reduce the likelihood that a connector of some type may bereattached to the distal end 201 b of the single-use connector 201either accidentally or intentionally. The goals of reducing thelikelihood that the single-use connector 201 is removed before thesingle-use connector 202 and helping to prevent the reattachment of aconnector onto the distal end 201 b of the single-use connector 201 canalso be accomplished by design features external to the overallconnector assembly or arrangement 10. For example, once the single-useconnector 200 is attached to the multi-use connector 101, a feature on afluid injector or its housing could grasp the single-use connector 201so that it cannot be removed until the user takes some action,optionally removing the single-use connector 202. Additional mechanicalor electromechanical strategies known to those skilled in the medicalarts may be used to accomplish this interlocking or mistake-reducingfunction.

In summary, referring specifically to FIG. 3, the overall connectorassembly or arrangement 10 is shown. In exemplary use of the connectorassembly 10, the single-use connector assembly 200 is connected to themulti-use connector assembly 10. Such a connection is established byremoving the cap 110 from the multi-use connector 101, for example in aflow of sterile air as described herein, removing the cap 210 from thefirst single-use connector 201, and then mating the multi-use connector101 to the first single-use connector 201. Once a secure fluid tightconnection between the foregoing connector elements is made, fluid froma fluid source or a fluid delivery device may be delivered to the fluidpath element 301 via the single-use connector assembly 200, and eitherimmediately or ultimately to a patient as desired. In one particularapplication, a programmable power fluid injector or an infusion pump maybe used to deliver a predetermined amount of fluid from an associatedfluid delivery device (e.g., a syringe or a pump cassette). Such a fluiddelivery apparatus is capable of developing sufficient pressure to drivefluid through the low-pressure restrictions of the plurality of flowcontrol elements 111, 211, 212, and/or 311 if they are provided in theflow path of the fluid. Alternatively, some or all of the flow controlelements 111, 211, 212, and/or 311 may be absent or may be biased openwhen the respective connector elements are connected to allow flow atvery low pressures or to allow the measurement of downstream pressures,for example blood pressure in the patients. After completion of a fluiddelivery procedure and/or when it is desired to remove the secondsingle-use connector 202 from connection with the first single-useconnector 201, the user grips second sheath element 251 b and twists.This twisting motion tears serrations (not shown) separating the secondsheath element 251 b from the first sheath element 251 a and, further,separates the first single-use connector 201 from the adjoiningsingle-use connector 202, with the first single-use connector 201remaining in fluid connection with the multi-use connector 101, as shownin FIG. 4. The single-use connector 201 that remains connected to themulti-use connector 101 now serves the function of a removable sterile“cap” for the multi-use connector 101.

A further technique for preserving the sterility of the multi-useconnector 101 during attachment therewith of the single-use connectorassembly 200 having two (2) or more single-use connectors 201, 202 willnow be described with additional reference to FIGS. 5-6. As describedpreviously, each assembled connector assembly 10 includes a multi-useconnector 101 and a plurality of single-use connectors 201, 202 insecure fluid connection with each other. The first single-use connector201 is coupled to the multi-use connector 101, while the secondsingle-use connector 202 is coupled to the preceding single-useconnector 201, as described previously. The initial connection betweenthe first single-use connector 201 and the second single-use connector202 is desirably established during the manufacture and packaging of thesingle-use connector assembly 200. As such, it is possible to closelymonitor and control the production environment and ensure that a“pre-coupled” sterile connection is present between the first single-useconnector 201 and the second single-use connector 202.

Once the multi-use connector assembly 100 and the single-use connectorassembly 200 are removed from their packaging, these components arejoined together to form the connector assembly 10. During the connectionstep for connecting the first single-use connector 201 to the multi-useconnector 101, it may be desirable to join the multi-use connector 101to the single-use connector 201 in an enhanced sterile environment. FIG.5 shows this connecting step between the first single-use connector 201and the multi-use connector 101 in conjunction with a stream of sterileair 450. The use of sterile air 450 in making the connection between themulti-use connector 101 and the single-use connector 201 provides anadditional measure of sterility protection by reducing the likelihood ofairborne particulates accumulating on the mating surfaces of the firstsingle-use connector 201 and the multi-use connector 101 between thetime the protective caps 110, 210 are removed and the connection betweenthese elements is completed. In FIG. 5, the stream of sterile air 450,which may be created by a fan and a HEPA filter with a preferredfiltering capacity, is directed through air plenum 410 to flow over themulti-use connector 101 in a direction that is generally parallel to thefluid flow axis 99(3) along the longitudinal length of the connectorassembly 10. In this manner, the multi-use connector 101 is disposed ina stream of sterile air even when the caps 110, 210 are removed in theprocess of making a connection with the first single-use connector 201.The stream of sterile air 450 may be operating continuously or may beselectively turned on during the connection process and then selectivelyturned off to conserve energy and filter life once the connection ismade. The air plenum 410 may be part of a housing of a power fluidinjector (not shown) that accepts a syringe to which, for example, themulti-use connector 101 is attached. A controller associated with thepower fluid injector may operate the air plenum 410 in the mannerdescribed in the foregoing.

With reference to FIG. 6, an alternative embodiment is shown in whichthe stream of sterile air 450 is generally perpendicular to the generalfluid flow direction along the fluid flow axis 99(3) and to the commonconnection direction. This alternative embodiment has a benefit in thatit may be easier for the user to ensure the sterility of the connectionby removing the cap 210 from the first single-use connector 201 insterile air, dispose of the cap 210, and then make a connection to themulti-use connector 101 in a downward stream of air. The stream ofsterile air 450 may also use part of the housing of a power fluidinjector (not shown) as part of air plenum 410 or be incorporated as aseparate hood or air plenum structure.

With reference to FIGS. 7-9, a general operational sequence forassembling and disassembling the connector assembly 10 is shown. InFIGS. 7-9, the multi-use connector 101 with attached removable cap 110is shown connected with a fluid delivery device such as a syringe 400for a power fluid injector (not shown). The single-use connectorassembly 200, as described previously, includes a first single-useconnector 201 covered by a cap 210, a connected second single-useconnector 202, and, further, a fluid path element 300 connected to thesecond single-use connector 202. As an example, the fluid path element300 may be low pressure connector tubing 302 adapted for connection to acatheter. FIG. 8 shows that the removable cap 110 has been removed fromthe multi-use connector 101, the removable cap 210 has been removed fromfirst single-use connector 201, and the first single-use connector 201is connected to the multi-use connector 101, which permits fluidcommunication between the syringe 400 and the fluid path element 300.Referring next to FIG. 9, the second single-use connector 202 is showndisconnected from the first single-use connector 201, leaving the firstsingle-use connector 201 in place connected to the multi-use connector101 for sterility purposes. The second single-use connector 202 andattached fluid path element 301 may be discarded as medical waste.

Referring next to FIGS. 10-12, an embodiment is shown that isspecifically adapted for the filling syringes. In FIGS. 10-12, a spike500 is connected by medical tubing 520 to the multi-use connector 101.The spike 500 is used for connection to a pharmacy bulk pack (not shown)and like containers from which contrast or other drugs may be drawn tofill multiple syringes for multiple patients. The single-use connectorassembly 200 comprising single-use connectors 201, 202 may be used toestablish fluid communication between the multi-use connector 101 andfluid path element 301, in this case the syringe neck connection 301 ofa syringe 400. The connection operation in the present embodiment isexactly the same as described previously, wherein the first single-useconnector 201 remains behind to protect the sterility of the multi-useconnector element 101. When the second single-use connector 202 isseparated from the first single-use connector 201, the second single-useconnector 202 and the syringe 400 remain connected, thus preserving thesterility of the syringe neck connection 401 of the syringe 400, whichmay subsequently be placed in a fluid injector. Once the syringe 400 isloaded in a fluid injector, the single-use connector 202, which isserving as a cap on the syringe neck 401, is removed and the syringeneck 401 can be directly connected to tubing (not shown) to carry thefluid in the syringe 400 to a single patient, or the syringe neckconnection 401 may be considered to “become” the multi-use connector 101of FIGS. 1 and 3 and be used with methods and devices of this disclosureto deliver fluid to a plurality of patients. The use of sterile airflowin the manner described previously, may be used in the presentsyringe-filling illustration to further enhance sterility when makingthe above-described connections.

In a typical application of the connector assembly 10 in a fluiddelivery procedure, once the fluid delivery procedure is completed usingthe multi-use connector 101, single-use connector assembly 200, andfluid path element 300, the proximal end 202 a of the “downstream”single-use connector 202, which is furthest away from the multi-useconnector 101, is removed from the distal end 201 b of the firstsingle-use connector 201. This removal also removes the “used” fluidpath element 300 along with the “downstream” single-use connector 202.Once the “used” distal-most single-use connector 202 and fluid pathelement 300 are removed from the adjoining or upstream single-useconnector 201, the connection assembly 10 is ready for subsequent reuse,if so desired. The first single-use connector 201 remains attached tothe multi-use connector 101 as shown in FIG. 4. This remainingsingle-use connector 201 now performs a similar function to the dust cap110, described previously, which is to retain sterility of the multi-useconnector 101. Next, in order to make a second connection to themulti-use connector 101, a “new” single-use connector assembly 200, suchas that shown in FIG. 2, is removed from its packaging. The cap 210 isremoved from the “new” single-use connector 201, and the “used”single-use connector 201 is removed from the multi-use connector 101.The multi-use connector 101 and the “new” single-use connector 201 maybe mated as before to form a new connection for delivery of fluidinvolving the same or a new patient. This procedure may be repeateduntil the fluid supply runs out or the fluid path upstream of themulti-use connector 101 needs to be changed for any reason, such asreaching a preset permitted number of uses, procedures, time, orpatients.

Referring next to FIGS. 13-15, FIG. 13 shows an embodiment that addsanother feature to multi-use connector assembly 100 in the form apreferably cylindrical, coaxial guard 102 which makes it more difficultfor there to be inadvertent contact with the sterile multi-use connector101 by recessing the multi-use connector 101 into the guard 102. FIG. 14shows a corresponding modification to the single-use connector assembly200 in which the first single-use connector 201 is sized to fit withinthe cylindrical, coaxial guard 102 and form a sealed fluid path with themulti-use connector 101. When the dust covers 110 and 210 are removedfrom their respective connectors, as single-use connector assembly 200is brought towards multi-use connector assembly 100, the guard 102prevents the potentially non-sterile aspects of single-use connectorassembly 200, for example, sheath 251, from touching the sterile aspectsof multi-use connector assembly 100, which is multi-use connector 101.FIG. 15 shows the assembled fluid path, with multi-use connector 101sealably mated with the first single-use connector 201 and thus able totransmit fluid to the remainder of the fluid path elements. Thisembodiment and others described hereinafter may optionally have the dustcaps 110, 210 provided as simple flat sheets of material that can beadhesively or heat sealed onto the respective connector assemblies 100,200 and simply peeled-off by the user.

Referring next to FIG. 16, another embodiment of the connector assembly10 is shown and generally includes the multi-use connector assembly 100and the single-use connector assembly 200 as described previously, butnow the connector assembly 10 exhibits a multiple port configuration. Inthis embodiment, as in previous embodiments, the single-use connectorassembly 200 includes multiple single-use connectors 201, 202 asdescribed previously, but now the single-use connector assembly 200shown in FIG. 16 is provided as a branch from a port on the multi-useconnector assembly 100. The presently illustrated multi-use connectorassembly 100 further comprises an additional, sterile multi-useconnector 101′ with an attached cap 110′. Once the cap 110′ is removed,another single-use connector assembly 200 (not shown) may be joined tothe multi-use connector assembly 100 at the multi-use connector 101′,resulting in the multi-ported connector assembly 10. Upon connection ofthe multi-use connector assembly 100 and the branch single-use connectorassembly 200 shown in FIG. 16, fluid can flow through the branchsingle-use connectors 201, 202 as desired. When the branch single-useconnector 202 is removed, the anti-drip or anti-reflux flow controlelement 211 in the single-use connector 201 seals the fluid path againstany fluid flow at normal operational pressure, in the same manner asdescribed previously. The establishment of a second fluid connection isavailable through another single-use connector assembly 200 (not shown)added to the multi-use connector 101′, which is accessed by removingdust cap 110′. As illustrated in this embodiment, the fluid path throughthe connector assembly 10 need not be linear or coaxial, and can be ofany geometry that one skilled in the art finds advantageous in theirparticular situation. Likewise, connector attachment and separations canutilize various geometries.

In the discussion hereinafter, various embodiments of the connectorassembly 10 are described that draw on the elements and featuresdescribed hereinabove in this disclosure, or are common from oneembodiment to the next. As such, for brevity and clarity, the followingembodiment descriptions do not recite or describe elements or featuresthat have been previously discussed elsewhere in this disclosure. In thefollowing embodiments, a generic fluid path element 300 comprisingtubing 302 with an overmolded filler piece 303 is shown in the views ofthe respective views for exemplary purposes.

Referring to FIGS. 17-21, an embodiment of the connector assembly 10 isshown that is suited for high pressure applications such as angiographyusing an angiographic syringe 40. A suitable high pressure syringe 40adapted to interface with a power injector may be found in United StatesPatent Application Publication No. 2009/0216192 to Schriver et al.,incorporated herein by reference for teachings related to the highpressure syringe 40. The high pressure syringe 40 generally comprises anelongated, cylindrical syringe body 42 having a front or distal end 44and a rear or proximal end 46. The syringe body 42 generally defines aninjection section 48 at the distal end 44 and an expansion section 50 atthe proximal end 46. A generally cylindrical center or working section52 of the syringe body 42 connects the injection section 48 and theexpansion section 50. The center or working section 52 has a relativelyuniform outer diameter. The injection section 48 tapers to form anelongated discharge neck 54. The injection section 48 and discharge neck54 generally form the discharge outlet of the syringe 40. The expansionsection 50 accommodates a syringe plunger (not shown). The injectionsection 48 is formed with a hollow alignment flange or tab 56 fororienting and aligning the syringe 40 in the power injector.Additionally, the proximal end 46 of the syringe body 42 defines anoutward extending radial lip 58. The radial lip 58 is adapted to engageor contact an electrical contact switch in the power injector toactivate the electrical switch to identify when the syringe 40 isproperly loaded in the power injector. The radial lip 58 preferably hasan outer diameter that is no greater than the outer diameter of thecenter or working section 52 of the syringe body 42 so that the syringe40 may be smoothly accepted into a pressure jacket (not shown)associated with the power injector during a syringe-loading procedure.

In this embodiment, after removing caps 110, 210, described previously,the single-use connector assembly 200 is threaded onto the multi-useconnector 101, provided on the discharge neck 54 of the syringe 40 orformed integrally as part of the discharge neck 54 as shown, using, forexample, a right-hand threaded engagement and is ready for use. Thesheath 251 surrounds the single-use connector assembly 200 and has acircumferential notch or serrated connection 251 n that separates thefirst sheath element 251 a from the second sheath element 251 b. Theseal between the single-use connectors 201, 202 occurs at elastomericflow control elements 211, 212. The force maintaining the seal betweenthe single-use connectors 201, 202 against the pressure of injection canbe created by joining the single-use connectors 201, 202 during or aftermanufacture and/or by having the sheath 251 lock over the collar 60, orby having threads, bayonet fittings, or other mechanical connections(not shown) between the sheath 251 and the single-use connector 201. Thesingle-use connector 201 is able to withstand the axial fluid pressureduring operation of the syringe 40 by having right-handed threadsbetween the multi-use connector 101 and the single-use connector 201.The single-use connector 201, in this example, is comprised of two (2)connector elements 201 x and 201 y fitted together by a barbedconnection or another suitable connection arrangement. In the presentembodiment, the first sheath element 251 a is a ratchet that preventsdisengagement of the right-handed threads when engaged with a collar 60on the discharge neck 54 of the syringe 40. In use, when a user is readyto unthread the single-use connector assembly 200, the sheath 251separates at circumferential notch 251 n, leaving the single-useconnector 201 behind as a sterility retaining cap. As mentionedpreviously, restraint against axially-directed forces or loads can befurther enhanced by optionally having tabs 251 x formed as part of firstsheath element 251 a that engage a collar 60 on the discharge neck 54 ofthe syringe 40. The second sheath element 251 b can be removed in theprocess of or after unthreading the single-use connector 201, so that anew single-use connector assembly 200 can be attached for the next use.

Referring next to FIGS. 22-26, a frangible connection may be provided aspart of the single-use connector assembly 200. As in the immediatelyforegoing embodiment, the multi-use connector 101 is provided on thedischarge neck 54 of the syringe 40 or formed integrally as part of thedischarge neck 54 as shown. In this embodiment, the single-use connector202 is rotatably connected to the opposing single-use connector 201.Additionally, the single-use connector 202 is adapted to break apartalong a thinned section 220 (e.g., a circumferential notch) such that,upon breaking, a portion 222 of the single-use connector 202 may be saidto be retained with the opposing single-use connector 201. The opposingsingle-use connector 201 is formed as a sheath part that is in threadedengagement with the multi-use connector 101. In the discussion of thisand other embodiments described herein, it may be considered that thesingle-use connector 202 ends at the break point, and the single-useconnector 201 is comprised of several physical parts, one of which isthe segment that remains behind after breaking at thinned section 220.This illustrates the principle that individually identified fluidelements can be assembled from discrete physical parts, orcomplimentarily, a single physical part may serve or function as part orall of one or more individually identified or discussed fluid pathelements. Or, said another way, the key aspects or functions of thevarious fluid path elements may be achieved with one or more than onephysical part or as part of a physical part.

In use, the single-use connector assembly 200 comprising connectors 201,202 is threaded onto the multi-use connector 101 on the discharge neck54 of the syringe 40, and the syringe 40 is then ready for use. Todisconnect, the user grasps wings W on the single-use connector 202 andtwists. This rotational motion breaks the thinned section 220,physically separating portion 222 from the main body of the single-useconnector 202, and the separated portion 222 is retained with theopposing single-use connector 201, which associated with the multi-useconnector 101. In the present embodiment where a frangible element isused, it is desirable for a power injector associated with the syringe40 or other associated equipment to have a strain relief notch, latch,or cover to prevent inadvertent disconnection.

Referring next to FIGS. 27-30, the single-use connector assembly 200 mayexhibit a sliding connection between elements. As in the immediatelyforegoing embodiments, the multi-use connector 101 is provided on thedischarge neck 54 of the syringe 40 or formed integrally as part of thedischarge neck 54 as shown. The single-use connector 202, in thisexample, is comprised of two (2) sliding connector elements 224, 226.The first connector element 224 comprises a depending portion 228adapted to fit within a mating receptacle 230 defined in the opposingconnector element 226 of the single-use connector 202. The secondconnector element 226 is secured to the opposing single-use connector201 by a barbed connection or another suitable connection arrangement,as described previously in connection with FIGS. 17-21. In thisembodiment, the flow control element 212 in the receiving connectorelement 226 of the single-use connector 202 incorporates a raised area232 to seal to a mating surface of the opposing the flow control element211 in the sliding connector element 224. In this embodiment, the sheath251 may be in the form of heat shrink wrapping with a tab 252 havingserrations (not shown) to assist in removal of the sheath 251. Thesheath 251 discourages accidental disconnection of the single-useconnector 202. Once the sheath 251 is removed, the connector elements224, 226 of the single-use connector 202 can be detached from oneanother, and the connector element 224 and the tubing 302 of the fluidpath element 300 connected thereto can be discarded.

Referring to FIGS. 31-33, a modification of the single-use connectorassembly 200 of FIGS. 27-30 is shown. In this embodiment, the secondconnector element 226 of the single-use connector 202 has two (2)folding elements 234, 236 that fold over an end or head portion 238 ofthe first connector element 224 to hold the single-use connector 202together and in a position mated with the single-use connector 201. Thefrangible sheath 251 holds the folding elements 234, 236 in place andsecures the connection. When the frangible sheath 251 is removed, thefolding elements 234, 236 separate and cannot maintain the connectionbetween the single-use connectors 201, 202. The folding elements 224,226 may be formed to be biased apart from one another. This embodimenthas an additional benefit of not being easily or accidentallyreconnected.

In FIGS. 34-35, a further modification of the single-use connectorassembly 200 of FIGS. 27-30 is shown. In this embodiment, the first andsecond connector elements 224, 226 of the single-use connector 202 arein abutting engagement and held together by the frangible shrink wrapsheath 251 alone, which secures their connection. When the frangiblesheath 251 is removed by pulling pull tab 252 or gripping and snappingthe single-use connector 202 to tear the frangible sheath 251, the firstand second connector elements 224, 226 separate from one another. FIGS.34-35 also show an alternative embodiment for the internal flow controlelement 211. The flow control element 211 may be in the form of anelastomeric solid cylinder disposed between an annular element 240provided between the first and second connector elements 224, 226 and aninternal shoulder 242 defined in the connector element 226. When thereis no pressure across the cylinder flow control element 211, thecylinder flow control element 211 seals against the internal shoulder242. When pressure on the right side of the cylinder flow controlelement 211 (as shown in FIG. 35) is greater than pressure on the leftside, the cylinder flow control element 211 is compressed slightly andfluid can flow. A seal 243 having some adhesion to the parts abutting itmay be provided to augment the strength of the connection between thefirst and second connector elements 224, 226.

In FIGS. 36-37, another embodiment of the single-use connector assembly200 is shown. In this embodiment the sheath 251, which is non-frangiblein this embodiment, is adapted for a threaded connection to thesingle-use connector 201 via, for example, left-handed (e.g.,counterclockwise-operated) threads. The sheath 251 provides the holdingforce to hold and seal the single-use connector 202 to the single-useconnector 201. The single-use connector 201 is adapted for threadedengagement with the discharge neck 54 of the syringe 40 via, forexample, right-handed (e.g., clockwise-operated) threads. In use, afterremoving the respective dust caps 110, 210 (discussed previously), thesingle-use connector 201 is threaded onto the multi-use connector 101provided on the discharge neck 54 of the syringe 40 or formed integrallywith the discharge neck 54 using the right-handed threaded engagement.Thus, the single-use connector 201 is placed in engagement with themulti-use connector 101 on the discharge neck 54 of the syringe 40 byrotating the single-use connector 201 clockwise. After use, to separatethe single-use connector 202 from the opposing single-use connector 201,the sheath 251 is held and rotated clockwise to release the engagementowing to the left-handed threaded engagement. By providing the foregoingleft-handed/right-handed threaded engagements, the risk of removing theconnection between the single-use connector 201 and the multi-useconnector 101 on the discharge neck 54 of the syringe 40 can be reducedand potentially eliminated. As will be apparent to those skilled in theart, the foregoing left-handed/right-handed threaded engagements may bereversed. As an alternative, the foregoing left-handed/right-handedthreaded engagements may be replaced by similar left-handed/right-handedbayonet connections or other equivalent securing methods may be used.The embodiment shown in FIGS. 36-37 utilizes a similar cylinder flowcontrol element 211 as shown in FIG. 35, but the annular element 240 isnow provided axially between the opposing single-use connectors 201, 202and abuts an internal shoulder 244 defined in single-use connector 201.

Referring to FIGS. 38-42, for simplicity of manufacture and reducedcost, the single-use connectors 201, 202 may be manufactured from asingle piece of plastic. In this embodiment, the flow control element211 may also be a single plastic piece, but now adapted to fit onto theend of the single-use connector 201 in an analogous manner to a waterbottle cap. The flow control element 211 is preferably elastic and mayincorporate bulges or rings 245 that seal against the inner surface ofthe multi-use connector 101, which may again be provided on thedischarge neck 54 of the syringe 40 or formed integrally as part of thedischarge neck 54. In this embodiment, tubing 302, which forms part ofthe fluid path element 300, may be bonded to the single-use connector202, optionally with a filler piece 303, which is also shown inconnection with tubing 302, as shown in previous figures as well. Tooptimize assembly via, for example, two-shot molding or overmoldingprocesses, the lumen through the single-use connectors 201, 202 can bestraight or tapered to accommodate a core pin to support the molding offlow control element 211 onto the single-use connector 201.

In use, the single-use connector 201 may be formed with bayonet slots246 that may be engaged with mating bayonet tabs 247 on the multi-useconnector 101 provided on the discharge neck 54 of the syringe 40. Thisengagement may be secured by rotating on or the other of the single-useconnector 201 and syringe 40 by 90°. Flexing elements 248 are providedon the single-use connector 201 to prevent the reversal of this bayonetconnection once engaged. Fluid can now be transmitted through theconnector assembly 10. To remove the single-use connector 202 from theopposing single-use connector 201, wings W on the single-use connector202 are held and twisted. Because of the locking of the bayonetconnection, they can be twisted in either direction. To remove thesingle-use connector 201 for installation of a new single-use connectorassembly 200 after the single-use connector 201 has been used as asterile cap, the single-use connector 201 may be gripped and twisted tobreak the single-use connector 201 along a weakened section or scoreline S (e.g., a circumferential notch) into two elements, a cap element249 and a ring element 250. The cap element or part 249 can be removedand the multi-use connector 101 is again ready for use. The ring elementor part 250 may remain in place. After each use, another ring element250 accumulates. By choosing the size of the ring element 250 and thelength of the fluid path element on which they accumulate, such as onthe discharge neck 54 of the syringe 40, the accumulation of ringelements 250 can be used to physically limit the number of times thatthe syringe 40 and/or multi-use connector 101 is utilized, for the sakeof sterility, safety, reliability, etc. Alternatively, tabs, scorelines, and other similar features (not shown) may be provided to allowthe user to break the ring elements 250 for removal after connection ofa new single-use connector assembly 200. Optionally, the multi-useconnector 101 may incorporate a feature such as a wedge or edge (notshown) that automatically splits the ring elements 250 as they arepushed away from the multi-use connector 101 so that the ring elements250 fall from the fluid path or can subsequently be removed by the user.

The above-described connector assembly 10 may be applied to a variety ofexisting medical systems. For example, the various fluid elements shownin U.S. Pat. Nos. 5,806,519, 5,840,026; 5,739,508; 5,569,181 and5,843,037, all of which are fully incorporated herein by reference, maybe used with any of the features described hereinabove. In theconnection steps described previously, a sterile airflow may bedesirable during the action of uncapping of connectors and/or connectingthe first single-use connector 201 to the multi-use connector 101.However, it should understood that, according to this disclosure,sterile air need not be flowing during disconnection of the firstsingle-use connector 201 in any of the foregoing embodiments because thefirst and second single-use connectors 201, 202 serve as sterilityretaining “caps” for their respective fluid path segments, and the useof sterile air is provided to enhance sterility.

Much of the foregoing discussion has centered upon the fluid supply sideof a fluid delivery system. However, the various embodiments describedhereinabove may be applied to the patient side where there is often aneed for multiple fluid lines for delivery or withdrawal of fluids andwhich must be connected sequentially to a patient access device over thetime of their treatment. The embodiments described hereinabove may beapplied to patient side of a fluid delivery to improve sterility throughthese multiple connections to a patient access device. In addition, asan example, the internal flow control elements 211, 212 provideadditional benefits by reducing the likelihood that blood willinadvertently leak from the patient access device. In practicalapplication, the internal flow control elements 211 and 212 desirablytightly abut one another so that no blood or bodily fluid is trappedtherebetween for subsequent release when the two (2) single-useconnectors 201, 202 are separated.

The exemplary embodiments described hereinabove are all generallydirected to a plurality of single-use connectors 201, 202 which form afluid path or fluid path element to or from a multi-use connector 101,wherein removal of one or more of the single-use connectors 201, 202,optionally with additional fluid path elements, leaves at least onesingle-use connector 201, 202 as protection on the multi-use connector101.

Lastly, referring to FIG. 43, an embodiment is shown in which theconnection between the multi-use connector assembly 100 and thesingle-use connector assembly 200 is made by sliding the single-useconnector 201 into a slot 1000 to hold it in place in relation tomulti-use connector 101. The slot 1000 may be part of the multi-useconnector 101 or the multi-use connector 101 may be attached to orintegrated as part of an apparatus, such as a fluid pump device. Whenthe single-use connector 201 is properly positioned, the flow controlelement 111 mates with the opposing flow control element 211 or theopposing single-use connector 201, to form a seal which prevents theleakage of fluid during use. As in previous embodiments, after use, thesingle-use connector 202 may be removed, for example by twisting orbreaking, and the opposing single-use connector 201 remains in place toretain the sterility of the multi-use connector 101. Optionally,single-use connector 201 and/or slot 1000 may have ratchets, ramps, orother mechanical or electrical means such that sliding can only occur inone direction. Also optionally, the connection may be configured suchthat the only way to remove the single-use connector 201 is bydislodging the single-use connector 201 from the slot 200 by using a newsingle-use connector assembly 200. This embodiment has a benefit thatthere never is a time when the fluid control element 111 is open andaccessible for accidental contact, even when removing the dust cap 110,or “used” connectors 201 serving as dust caps as described previously,which may be removed by application of the first single-use connectorassembly 200 or a subsequent single-use connector 201 in a subsequentsingle-use connector assembly 200. In another variation, multiplesterile single-use connectors 201 may be prepackaged in a magazine whichmates with the slot 1000 to provide for easy loading of new fluid paths.Also, if this embodiment is used with a catheter inserted into apatient, the fluid path element 300 (as well as the fluid path into themulti-use connector 101) can be parallel to the sliding element ratherthan perpendicular as show in this figure. This low profile arrangement,which is optionally curved or barrel-shaped, may make it much easier totape to a patient's arm and a low profile connector reduces thepossibility of inadvertent contact with unsterilized surfaces. Moreover,when used with a catheter, it is desirable to have sterilized caps 110available that can be placed on the multi-use connector 101 when thepatient is not connected to a fluid path element 300.

While several embodiments of a sterility retaining medical connectorassembly and method for retaining sterility of a reusable portion of themedical connector assembly are shown in the accompanying figures anddescribed hereinabove in detail, those skilled in the art may makemodifications and alterations to these embodiments without departingfrom the scope and spirit of the invention. Accordingly, the foregoingdescription is intended to be illustrative rather than restrictive. Theinvention is defined by the appended claims and all changes to theinvention that fall within the meaning and the range of equivalency ofthe claims are to be embraced within their scope

1. A medical connector assembly, comprising: a multi-use connectorcomprising a proximal end opposite a distal end along a longitudinallength thereof; and a plurality of single-use connectors connected inseries and each comprising a proximal end opposite a distal end along alongitudinal length thereof, wherein the distal end of the multi-useconnector is releasably connected to the proximal end of a first of theserially-connected single-use connectors, and wherein when a second ofthe serially-connected single-use connectors is disconnected from thefirst single-use connector, the first single-use connector remainsconnected to the multi-use medical connector as a sterility retainingcover.
 2. The medical connector assembly according to claim 1, furthercomprising a removable cap adapted to cover the distal end of themulti-use connector or the proximal end of the first single-useconnector in the plurality of serially-connected single-use connectorsto retain sterility.
 3. (canceled)
 4. The medical connector assemblyaccording to claim 1, further comprising a sheath disposed over theexterior of the medical connector assembly to extend from the multi-useconnector and continuing along the serially-connected single-useconnectors, the sheath comprising a first sheath element having afrangible connection to a second sheath element.
 5. (canceled)
 6. Themedical connector assembly according to claim 4, wherein when the secondsingle-use connector is disconnected from the first single-useconnector, the first sheath element remains disposed about the firstsingle-use connector and a portion of the multi-use medical connectorand the second sheath element remains disposed about the disconnectedsecond single-use connector.
 7. The medical connector assembly accordingto claim 1, further comprising a fluid path element connected to thedistal end of the second single-use connector. 8-9. (canceled)
 10. Amethod of establishing and retaining a sterile fluid connection in amedical connector assembly, comprising the steps of: providing amulti-use connector comprising a proximal end opposite a distal endalong a longitudinal length thereof; providing a plurality of single-useconnectors connected in series and each comprising a proximal endopposite a distal end along a longitudinal length thereof; connectingthe distal end of the multi-use connector to the proximal end of a firstof the serially-connected single-use connectors; and disconnecting asecond of the serially-connected single-use connectors from the firstsingle-use connector, such that the first single-use connector remainsconnected to the multi-use medical connector as a sterility retainingcover.
 11. (canceled)
 12. (canceled)
 13. The method according to claim10, further comprising a sheath disposed about the medical connectorassembly and comprising a first sheath element having a frangibleconnection to a second sheath element, and wherein when the secondsingle-use connector is disconnected from the first single-useconnector, the frangible connection is broken. 14-18. (canceled)
 19. Themethod according to claim 10, wherein the step of disconnecting thesecond single-use connector from the first single-use connectorcomprises twisting the second single-use connector relative to the firstsingle-use connector and axially detaching the second single-useconnector from the first single-use connector. 20-26. (canceled)
 27. Amedical connector assembly, comprising: a multi-use connector; aplurality of single-use connectors connected in series; and wherein themulti-use connector is releasably connected to a first of theserially-connected single-use connectors, and wherein when a second ofthe serially-connected single-use connectors is disconnected from thefirst single-use connector, the first single-use connector remainsconnected to the multi-use medical connector as a sterility retainingcover. 28-29. (canceled)
 30. The medical connector assembly according toclaim 27, wherein the first single-use connector is comprised of twoconnector elements fitted together in interfering engagement.
 31. Themedical connector assembly according to claim 27, further comprising afrangible sheath disposed about the medical connector assembly andcomprising a first sheath element having a frangible connection along acircumferential notch to a second sheath element.
 32. The medicalconnector assembly according to claim 27, wherein the second single-useconnector is adapted to break apart along a circumferential notch suchthat, upon breaking, a portion of the second single-use connector isretained with the opposing first single-use connector.
 33. The medicalconnector assembly according to claim 27, wherein the second single-useconnector is comprised of a first connector element and a secondconnector element, the first connector element defining a head portioncomprising a depending portion adapted for sliding engagement into amating receptacle defined in the second connector element. 34.(canceled)
 35. The medical connector assembly according to claim 27,wherein the second single-use connector is comprised of a firstconnector element and a second connector element, the first connectorelement defining a head portion and the second connector elementcomprising opposed folding elements that fold over the head portion. 36.(canceled)
 37. The medical connector assembly according to claim 27,wherein the second single-use connector is comprised of a firstconnector element and a second connector element in abutting engagementheld together by a frangible shrink wrap sheath.
 38. The medicalconnector assembly according to claim 27, wherein the first single-useconnector is in threaded engagement with the multi-use connector, andfurther comprising a threaded sheath in threaded engagement with thefirst single-use connector, and wherein the threaded engagement betweenthe sheath and the first single-use connector is oppositely operatedfrom the threaded engagement between the first single-use connector andthe multi-use connector.
 39. (canceled)
 40. The medical connectorassembly according to claim 27, wherein the single-use connectors areintegrally formed and adapted to break into two elements along acircumferential notch.
 41. The medical connector assembly according toclaim 27, further comprising a sheath disposed about the medicalconnector assembly and comprising a first sheath element having afrangible connection to a second sheath element.
 42. The medicalconnector assembly according to claim 41, wherein the sheath extendsover the exterior of the medical connector assembly to extend from themulti-use connector and continuing along the serially-connectedsingle-use connectors.
 43. The medical connector assembly according toclaim 42, wherein when the second single-use connector is disconnectedfrom the first single-use connector, the first sheath element remainsdisposed about the first single-use connector and a portion of themulti-use medical connector and the second sheath element remainsdisposed about the disconnected second single-use connector. 44-47.(canceled)